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Generics
Close on the heels of a price hike for anticoagulant drug heparin, India's pharma industry has been urging the government to initiate an upward price revision for another 25-30 drugs as raw material prices and other expenses eat into margins. 16 September 2020
Pharmaceutical
The USA’s National Institutes of Health (NIH) has launched two of three adaptive Phase III clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. 12 September 2020
Biotechnology
In a Securities Exchange Commission filing yesterday, California-based biotech BioMarin Pharmaceutical revealed it has received the European Medicines Agency's Joint Assessment Report related to the EMA’s ongoing review of the company’s Marketing Authorization Application for ValRox (valoctocogene roxaparvovec) for severe hemophilia A. 10 September 2020
Pharmaceutical
Liminal BioSciences has filed a resubmission of the Biologics License Application (BLA) for Ryplazim (plasminogen) with the US Food and Drug Administration for the treatment of congenital plasminogen deficiency (C-PLGD). 8 September 2020
Generics
Generic drugs major Mylan has reached an agreement to acquire the related intellectual property and commercialization rights of South Africa-headquartered Aspen Pharmacare’s thrombosis business in Europe. 8 September 2020
Biotechnology
Kite today announced that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Yescarta (axicabtagene ciloleucel). 4 September 2020
Biotechnology
Californian monoclonal antibody (Mab) specialist Xencor has entered a strategic collaboration with the University of Texas MD Anderson Cancer Center to study investigational treatments for patients with a variety of cancer types. 4 September 2020
Biotechnology
Gilead Sciences’ CAR-T subsidiary Kite and HiFiBiO Therapeutics have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML). 3 September 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML). 2 September 2020
Biotechnology
Privately-held US biopharma company Triumvira Immunologics has successfully completed a $55 million Series A financing round. 27 August 2020
Pharmaceutical
Swiss pharma giant Novartis has announced positive data from a primary analysis of the Phase III ASCEMBL study. 26 August 2020
Pharmaceutical
US pharma major Bristol Myers Squibb has announced a setback for its Phase III IDHENTIFY trial in relapsed or refractory acute myeloid leukemia (R/R AML). 25 August 2020
Pharmaceutical
One of Russia’s largest blood plasma fractionation plant will soon be built in the Tatarstan Republic, one of Russia’s most economically developed regions, by the Israeli biotech and pharmaceutical company Alishech, according to recent statements, made by representatives of the investor and representatives of the Russian federal government, reports The Parma Letter’s local correspondent. 25 August 2020
Biotechnology
Japan’s Ono Pharmaceutical has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval. 21 August 2020
Biotechnology
US biotech BioMarin Pharmaceutical opened 30% lower on Wednesday after a major setback. 19 August 2020
Biotechnology
Adcetris (brentuximab vedotin) is the market-leading drug in the world’s 7MM (the USA, France, Germany, Italy, Spain, the UK and Japan) markets and the main contributor to the market growth in Hodgkin’s lymphoma (HL) over the recent years. 19 August 2020
Biotechnology
The US Food and Drug Administration had accepted the New Drug Application (NDA) for umbralisib, an investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously-treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. 14 August 2020
Pharmaceutical
Danish pharma major Novo Nordisk has announced that trials in the concizumab Phase III program (explorer6, 7 and 8) are being resumed. 13 August 2020
Biotechnology
Danish biotech success story Genmab was 3% higher as Thursday’s trading entered its final third. 13 August 2020
Biotechnology
Despite gaining 1.9% pre-market, AbbVie shares were down 2% at $94.14 mid-morning after it announced financial results for the second quarter ended June 30, 2020. 31 July 2020
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s next health secretary, but the day brought good news for the group elsewhere in the business. 15 November 2024
Biotechnology
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Biotechnology
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
Pharmaceutical
An impressive set of quarterly financial results and an improved outlook for the rest of the year were announced by Bristol Myers Squibb on Thursday. 31 October 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
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